0 Ratings
ID

16777

Description

Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00560365

Link

https://clinicaltrials.gov/show/NCT00560365

Keywords

Versions (1)
  1. 8/7/16 8/7/16 -
Uploaded on

August 7, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Colorectal Cancer NCT00560365

    English

    Eligibility Colorectal Cancer NCT00560365

    1 forms  
    Criteria
    Description

    Criteria

    diagnosis of primary colorectal cancer
    Description

    Colorectal Carcinoma Primary

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009402
    UMLS CUI [1,2]
    C0205225
    stage i-iii disease
    Description

    TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3258246
    have undergone curative resection (i.e., no residual disease [r0])
    Description

    Excision Curative | Residual Tumor

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0728940
    UMLS CUI [1,2]
    C1276305
    UMLS CUI [2]
    C0543478
    microscopically clear margins
    Description

    Clear Surgical Margin Microscopic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1709157
    UMLS CUI [1,2]
    C0205288
    complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, ct pneumocolon, or virtual colonoscopy
    Description

    Diagnostic Imaging Colon Preoperative Complete | Diagnostic Imaging Colon Postoperative Complete | colonoscopy | Lower gastrointestinal tract contrast procedure | Computed Tomographic Colonography | Virtual CT colonoscopy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0009368
    UMLS CUI [1,3]
    C0445204
    UMLS CUI [1,4]
    C0205197
    UMLS CUI [2,1]
    C0011923
    UMLS CUI [2,2]
    C0009368
    UMLS CUI [2,3]
    C0445204
    UMLS CUI [2,4]
    C0032790
    UMLS CUI [2,5]
    C0205197
    UMLS CUI [3]
    C0009378
    UMLS CUI [4]
    C0203075
    UMLS CUI [5]
    C0935912
    UMLS CUI [6]
    C1635173
    post-operative blood cea ≤ 10 ng/ml (if the normal range is ≤ 5 ng/ml) or < 2 times upper limit of normal (if normal range is > 5 ng/ml)
    Description

    Carcinoembryonic antigen measurement Blood Postoperative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0201933
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0032790
    for patients undergoing adjuvant therapy, cea should be measured after completion of chemotherapy
    Description

    Adjuvant therapy | Carcinoembryonic antigen measurement Post Chemotherapy Complete

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0677850
    UMLS CUI [2,1]
    C0201933
    UMLS CUI [2,2]
    C0687676
    UMLS CUI [2,3]
    C0392920
    UMLS CUI [2,4]
    C0205197
    has completed primary curative treatment, as deemed by hospital clinician
    Description

    curative treatment Primary Complete

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1273390
    UMLS CUI [1,2]
    C0205225
    UMLS CUI [1,3]
    C0205197
    patients awaiting stoma closure allowed
    Description

    Surgical closure of stoma Patient awaiting procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0185019
    UMLS CUI [1,2]
    C0554950
    no evidence of metastatic disease on pre- or post-operative liver ct scan (or ultrasound) and chest ct scan (or chest x-ray)
    Description

    Neoplasm Metastasis Evidence | Computed Tomography (CT) of Liver Preoperative | Computed Tomography (CT) of Liver Postoperative | Ultrasonography of liver Preoperative | Ultrasonography of liver Postoperative | Chest CT Preoperative | Chest CT Postoperative | chest X-ray Preoperative | chest X-ray Postoperative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C3887511
    UMLS CUI [2,1]
    C0412621
    UMLS CUI [2,2]
    C0445204
    UMLS CUI [3,1]
    C0412621
    UMLS CUI [3,2]
    C0032790
    UMLS CUI [4,1]
    C0412534
    UMLS CUI [4,2]
    C0445204
    UMLS CUI [5,1]
    C0412534
    UMLS CUI [5,2]
    C0032790
    UMLS CUI [6,1]
    C0202823
    UMLS CUI [6,2]
    C0445204
    UMLS CUI [7,1]
    C0202823
    UMLS CUI [7,2]
    C0032790
    UMLS CUI [8,1]
    C0039985
    UMLS CUI [8,2]
    C0445204
    UMLS CUI [9,1]
    C0039985
    UMLS CUI [9,2]
    C0032790
    no diagnosis of familial adenomatous polyposis (fap) or dominantly inherited colon cancer
    Description

    Adenomatous Polyposis Coli | Colon Carcinoma dominant inheritance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032580
    UMLS CUI [2,1]
    C0699790
    UMLS CUI [2,2]
    C0678942
    patient characteristics:
    Description

    Patient Characteristics

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0815172
    no concurrent serious illness
    Description

    Illness Serious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205404
    history of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up
    Description

    Carcinoma First line treatment Complete | Recurrent disease Evidence | follow-up Interferes with Clinical Study Follow-up

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007097
    UMLS CUI [1,2]
    C1708063
    UMLS CUI [1,3]
    C0205197
    UMLS CUI [2,1]
    C0277556
    UMLS CUI [2,2]
    C3887511
    UMLS CUI [3,1]
    C1522577
    UMLS CUI [3,2]
    C0521102
    UMLS CUI [3,3]
    C3274571
    prior concurrent therapy:
    Description

    Prior Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1514463
    see disease characteristics
    Description

    disease characteristic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0599878
    pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved
    Description

    Rectal Carcinoma Therapeutic radiology procedure Preoperative | Rectal Carcinoma Chemoradiotherapy Preoperative | Excision Curative Complete

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007113
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C0445204
    UMLS CUI [2,1]
    C0007113
    UMLS CUI [2,2]
    C0436307
    UMLS CUI [2,3]
    C0445204
    UMLS CUI [3,1]
    C0728940
    UMLS CUI [3,2]
    C1276305
    UMLS CUI [3,3]
    C0205197
    no concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements
    Description

    Study Subject Participation Status Interferes with Clinical Study Follow-up

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C3274571
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    Similar models

    Eligibility Colorectal Cancer NCT00560365

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Colorectal Carcinoma Primary
    Item
    diagnosis of primary colorectal cancer
    boolean
    C0009402 (UMLS CUI [1,1])
    C0205225 (UMLS CUI [1,2])
    TNM clinical staging
    Item
    stage i-iii disease
    boolean
    C3258246 (UMLS CUI [1])
    Excision Curative | Residual Tumor
    Item
    have undergone curative resection (i.e., no residual disease [r0])
    boolean
    C0728940 (UMLS CUI [1,1])
    C1276305 (UMLS CUI [1,2])
    C0543478 (UMLS CUI [2])
    Clear Surgical Margin Microscopic
    Item
    microscopically clear margins
    boolean
    C1709157 (UMLS CUI [1,1])
    C0205288 (UMLS CUI [1,2])
    Diagnostic Imaging Colon Preoperative Complete | Diagnostic Imaging Colon Postoperative Complete | colonoscopy | Lower gastrointestinal tract contrast procedure | Computed Tomographic Colonography | Virtual CT colonoscopy
    Item
    complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, ct pneumocolon, or virtual colonoscopy
    boolean
    C0011923 (UMLS CUI [1,1])
    C0009368 (UMLS CUI [1,2])
    C0445204 (UMLS CUI [1,3])
    C0205197 (UMLS CUI [1,4])
    C0011923 (UMLS CUI [2,1])
    C0009368 (UMLS CUI [2,2])
    C0445204 (UMLS CUI [2,3])
    C0032790 (UMLS CUI [2,4])
    C0205197 (UMLS CUI [2,5])
    C0009378 (UMLS CUI [3])
    C0203075 (UMLS CUI [4])
    C0935912 (UMLS CUI [5])
    C1635173 (UMLS CUI [6])
    Carcinoembryonic antigen measurement Blood Postoperative
    Item
    post-operative blood cea ≤ 10 ng/ml (if the normal range is ≤ 5 ng/ml) or < 2 times upper limit of normal (if normal range is > 5 ng/ml)
    boolean
    C0201933 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0032790 (UMLS CUI [1,3])
    Adjuvant therapy | Carcinoembryonic antigen measurement Post Chemotherapy Complete
    Item
    for patients undergoing adjuvant therapy, cea should be measured after completion of chemotherapy
    boolean
    C0677850 (UMLS CUI [1])
    C0201933 (UMLS CUI [2,1])
    C0687676 (UMLS CUI [2,2])
    C0392920 (UMLS CUI [2,3])
    C0205197 (UMLS CUI [2,4])
    curative treatment Primary Complete
    Item
    has completed primary curative treatment, as deemed by hospital clinician
    boolean
    C1273390 (UMLS CUI [1,1])
    C0205225 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    Surgical closure of stoma Patient awaiting procedure
    Item
    patients awaiting stoma closure allowed
    boolean
    C0185019 (UMLS CUI [1,1])
    C0554950 (UMLS CUI [1,2])
    Neoplasm Metastasis Evidence | Computed Tomography (CT) of Liver Preoperative | Computed Tomography (CT) of Liver Postoperative | Ultrasonography of liver Preoperative | Ultrasonography of liver Postoperative | Chest CT Preoperative | Chest CT Postoperative | chest X-ray Preoperative | chest X-ray Postoperative
    Item
    no evidence of metastatic disease on pre- or post-operative liver ct scan (or ultrasound) and chest ct scan (or chest x-ray)
    boolean
    C0027627 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    C0412621 (UMLS CUI [2,1])
    C0445204 (UMLS CUI [2,2])
    C0412621 (UMLS CUI [3,1])
    C0032790 (UMLS CUI [3,2])
    C0412534 (UMLS CUI [4,1])
    C0445204 (UMLS CUI [4,2])
    C0412534 (UMLS CUI [5,1])
    C0032790 (UMLS CUI [5,2])
    C0202823 (UMLS CUI [6,1])
    C0445204 (UMLS CUI [6,2])
    C0202823 (UMLS CUI [7,1])
    C0032790 (UMLS CUI [7,2])
    C0039985 (UMLS CUI [8,1])
    C0445204 (UMLS CUI [8,2])
    C0039985 (UMLS CUI [9,1])
    C0032790 (UMLS CUI [9,2])
    Adenomatous Polyposis Coli | Colon Carcinoma dominant inheritance
    Item
    no diagnosis of familial adenomatous polyposis (fap) or dominantly inherited colon cancer
    boolean
    C0032580 (UMLS CUI [1])
    C0699790 (UMLS CUI [2,1])
    C0678942 (UMLS CUI [2,2])
    Patient Characteristics
    Item
    patient characteristics:
    boolean
    C0815172 (UMLS CUI [1])
    Illness Serious
    Item
    no concurrent serious illness
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    Carcinoma First line treatment Complete | Recurrent disease Evidence | follow-up Interferes with Clinical Study Follow-up
    Item
    history of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up
    boolean
    C0007097 (UMLS CUI [1,1])
    C1708063 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    C0277556 (UMLS CUI [2,1])
    C3887511 (UMLS CUI [2,2])
    C1522577 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C3274571 (UMLS CUI [3,3])
    Prior Therapy
    Item
    prior concurrent therapy:
    boolean
    C1514463 (UMLS CUI [1])
    disease characteristic
    Item
    see disease characteristics
    boolean
    C0599878 (UMLS CUI [1])
    Rectal Carcinoma Therapeutic radiology procedure Preoperative | Rectal Carcinoma Chemoradiotherapy Preoperative | Excision Curative Complete
    Item
    pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved
    boolean
    C0007113 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C0445204 (UMLS CUI [1,3])
    C0007113 (UMLS CUI [2,1])
    C0436307 (UMLS CUI [2,2])
    C0445204 (UMLS CUI [2,3])
    C0728940 (UMLS CUI [3,1])
    C1276305 (UMLS CUI [3,2])
    C0205197 (UMLS CUI [3,3])
    Study Subject Participation Status Interferes with Clinical Study Follow-up
    Item
    no concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements
    boolean
    C2348568 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C3274571 (UMLS CUI [1,3])
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